Canadian clinical trial registry

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Study Description

This is a Phase 1 clinical trial designed to study a drug called 23ME-00610 in children and adults with advanced solid tumors that have not responded to or gotten worse after stardard therapy, or where no further standard therapy exists. In Part A of this study, researchers are looking to find the best possible dose of 23ME-00610 (called the recommended phase 2 dose). Part B of this study will evaluate how the patients body responds to the drug 23ME-00610 and continue monitoring safety. 

Inclusion Criteria

• To enroll in Part B of the study, the patient must be  ≥ 12 years of age
• Patient must weigh at least 40kg
• Patient must have a solid tumor:
  • that has progressed after all available standard therapy
  • or for which standard therapy has been ineffective
  • or for which no standard therapy exists
• Patient is up and about for at least half of their waking hours 
• Patient must have a solid tumor that has not previously been exposed to radiation

Additional inclusion or exclusion criteria may apply and will be discussed with you by the study team 

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Study Description

This study is to find the appropriate dose as well as to assess the safety and effectiveness of a drug called quizartinib for children with relapsed or refractory acute myeloid leukemia (AML) with a certain mutation called FLT3-ITD. Quizartinib is a drug designed to specifically block the FLT3 protein when it is abnormal in a leukemia cell.

Inclusion Criteria

• Children 1 month to 21 years of age
• Acute myeloid leukemia that has come back or is not responding to current treatment
• Presence of the FLT3-ITD mutation in the leukemia
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This study will assess the molecular subtype (abbreviated WNT, SHH, Non-WNT, Non-SHH) of patients with medulloblastoma. Based on the subtype And other factors, patients will be assigned to a "risk group", each risk group receiving specific treatment with chemotherapy and radiation therapy.

Patients with a specific molecular subtype called Sonic Hedgehog (SHH) will be treated with a medication taken by mouth, called vismodegib in addition to standard therapy, to directly target the molecular pathway. 

Inclusion Criteria

• Patients between 3 and 22 years of age with medulloblastoma.
• Patients between 22 and 40 years with medulloblastoma of the SHH subtype are eligible.
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This study seeks to test the safety and effectiveness of the drug taken by mouth called idasanutlin when taken together with chemotherapy or other cancer drugs (venetoclax) to treat acute leukemias or solid tumors in pediatric or young adults. 

The study is divided into 3 parts. The first part of the study aims to figure out the maximum dose of idasanutlin that can be safely tolerated as well as the recommended dose of idasanutlin when used in combination with chemotherapy and other cancer drugs (venetoclax).

The second part of the study aims to test the safety and effectiveness of idasanutlin in combination with chemotherapy and other cancer drugs (venetoclax) for treating neuroblastoma, acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL).

The third part of the study further monitors patients for additional responses to idasanutlin and safety assessments.

Inclusion Criteria

• Age less than 18 years old or less than 30 years old depending on study groups
• Diagnosis of neuroblastoma, acute myeloid leukemia (AML), or acute lymphoblastic leukemia (ALL) that has worsened or come back despite the use of standard therapy.
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

The purpose of this study is to test the safety of a cancer drug called repotrectinib in children. The cancer must have a change in a particular gene (ALK, ROS1 or NTRK). Those gene changes lead to abnormal proteins which may cause cancer cells to grow. Repotrectinib blocks the actions of these genes in cancer cells and can therefore be used to treat cancer.

The first study part (Phase 1) is done to determine what dose level of repotrectinib is safe for children, how the drug is absorbed. This phase is now closed.

The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with repotrectinib.

This study is divided into 2 stages/phases.

The first stage or phase evaluates the safety and tolerability of the drug (repotrectinib) in patients with advanced cancers. This allows researchers to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) which can then be used to select the recommended dose for patients. This phase is now closed.

The second stage or phase will determine the effectiveness of the drug (repotrectinib) in treating advanced cancers.

Inclusion Criteria

For the first phase:

• Age <12 years
• Patients with advanced or metastatic cancer, including brain tumours or certain types of lymphoma
• The tumour must have a change in one of the following genes: ALK, ROS1 or NTRK
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

For the second phase:

• Age 12 to less than 25 years
• Patients with advanced or metastatic cancer, including brain tumours or certain types of lymphoma
• The tumour must have a change in one of the following genes: ALK, ROS1 or NTRK
• Some patients may be eligible even if they have already received another drug blocking NTRK in the past
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

In this study, researchers are trying to learn more about how safe the study medicine called Alectinib is, and how well they work for children and young people with certain solid or brain cancers where previous treatment has not worked or is not available.

Inclusion Criteria

• Patients must have a confirmed diagnosis of a brain tumour or solid tumor with a specific gene change called "ALK fusion"
• Patients must have a cancer that has come back (relapsed) or has no standard treatment available
• Patients must be 17 years old or younger to participate 
• Patients must be able to walk and do routine activities for more than half of their normal waking hours
• Patients must have a willingness to complete clinical assessments throughout the study (electronic, paper and/or interviewer methods)

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

The purpose of this research study is to investigate an experimental drug, MK-3475 (also called pembrolizumab), in young patients. The drug MK-3475 has been previously studied in adults, in a variety of tumors, but is not yet FDA approved. The first phase is a safety study to assess side effects and best dose of pembrolizumab, the second phase is the efficacy portion to see how well it works in treating childhood brain tumors that have come back (recurrent), progressed, or not responded (refractory) to previous treatment. 

(transcribed from PBTC-045 Summary for Patients and Families)

Inclusion Criteria

• Patient must have one of the following diagnoses that have come back, progressed or not responded to treatment, to be eligible: 
  • Stratum A : DIPG - currently closed to enrollment
  • Stratum B : Non-brainstem high-grade glioma (NB-HGG)
  • Stratum C : Hypermutated brain tumor
  • Stratum D : Ependymoma
  • Stratum E : Medulloblastoma 
• Patient must have been treated with prior radiation therapy and/or chemotherapy (exclusions apply)
• Both males and females of all races and ethnic groups are eligible for this study
• Patient must be able to be up and about more than 50% of their waking hours
• Age Requirements:
  • Stratum A  -  1 year to 18 years old during safety portion, <22 years during efficacy, currently closed to enrollment
  • Stratum B  - 1 year to 18 years old during safety portion, <22 years during efficacy
  • Stratum C  - Younger than 30 years old
  • Stratum D  - 1 year to 18 years old during safety portion, <22 years during efficacy
  • Stratum E  - 1 year to 18 years old during safety portion, <22 years during efficacy
• Patients must have satisfactory blood work prior to enrolling
• Patient must not have any shortness of breath
• Human immunodeficiency virus (HIV)-infected patients with undetectable viral load within 6 months are eligible for this trial
• Patients of child bearing potential must NOT be pregnant, and must agree to use 2 methods of birth control, be surgically sterile, or abstain from heterosexual activity while on study and 6 months after
• Patient and/or guardian must sign a written consent document

Additional inclusion and exclusion criteria may apply.

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Study Description

PBTC-049 tests a drug called savolitinib to see how well it works in children with these tumors. This drug has not been studied in children. The hope is that this drug may be a more effective treatment for these types of brain tumors in children.

Therefore, the primary goals of the study are to:

• Determine which dose of savolitinib is safe for children
• Learn what effects (good or bad) may occur when patients take savolitinib
• Learn how the body processes savolitinib

(via: PBTC-049_Summary for patients & families_05-18-2020.pdf)

Inclusion Criteria

• Patients with confirmed medulloblastoma, high-grade glioma, DIPG brain tumors, and other brain tumor types with a specific genetic marker, which continue to grow or have come back after the prior treatment may be eligible to participate.
• Patients must be between 5-21 years of age.
• Patients must have recovered from toxicities of all prior chemotherapy, immunotherapy, radiotherapy or any other treatment modality prior to entering this study.
• Pregnant women and nursing mothers are excluded from this study
• Patients or a parent/guardian must understand and sign a written consent form to participate
• Patients and/or their families must agree to the study visit requirements outlined in the consent form

(via: PBTC-049_Summary for patients & families_05-18-2020.pdf)

Other inclusion criteria may apply and will be discussed with you by the study team.